Journal Thoracic Oncology

NOW
THERE’S
OPDIVO is the only PD-1 inhibitor that delivered superior
OS vs. chemotherapy in two Phase III studies designed
to include PD-L1 expressors and non-expressors with
previously treated NSCLC 1
OPDIVO is indicated for the treatment of locally advanced or metastatic
non-small cell lung cancer (NSCLC) after prior chemotherapy in adults 1
OS – overall survival; PD-1 – programmed death-1; PD-L1 – programmed death-ligand 1
Reference: 1. OPDIVO Summary of Product Characteristics.
ABBREVIATED SMPC
▼ This medicinal product is subject to additional monitoring. This will allow quick
identification of new safety information. Healthcare professionals are asked to
report any suspected adverse reactions. See section 4.8 in the SmPC for how to
report adverse reactions.
NAME OF THE MEDICINAL PRODUCT: OPDIVO 10 mg/mL concentrate for
solution for infusion. Pharmacotherapeutic Group: Antineoplastic agents,
monoclonal antibodies. ATC code: L01XC17. QUALITATIVE AND QUANTITATIVE
COMPOSITION: Each mL of concentrate contains 10 mg of nivolumab. One vial
of 4 mL contains 40 mg of nivolumab. One vial of 10 mL contains 100 mg of
nivolumab. Nivolumab is produced in Chinese hamster ovary cells by recombinant
DNA technology. List of excipients: Sodium citrate dihydrate, Sodium chloride,
Mannitol (E421), Pentetic acid (diethylenetriaminepentaacetic acid), Polysorbate
80, Sodium hydroxide (for pH adjustment), Hydrochloric acid (for pH adjustment)
Water for injections. THERAPEUTIC INDICATIONS: Melanoma OPDIVO as
monotherapy or in combination with ipilimumab is indicated for the treatment of
advanced (unresectable or metastatic) melanoma in adults. Relative to nivolumab
monotherapy, an increase in progression-free survival (PFS) for the combination of
nivolumab with ipilimumab is established only in patients with low tumour PD-L1
expression (see sections 4.4 and 5.1 in the SmPC). Non-Small Cell Lung Cancer
(NSCLC) OPDIVO is indicated for the treatment of locally advanced or metastatic
non-small cell lung cancer (NSCLC) after prior chemotherapy in adults. Renal
Cell Carcinoma (RCC) OPDIVO as monotherapy is indicated for the treatment of
advanced renal cell carcinoma after prior therapy in adults. CONTRAINDICATIONS:
Hypersensitivity to the active substance or to any of the excipients listed in section
6.1 in the SmPC. MARKETING AUTHORISATION HOLDER: Bristol Myers Squibb
Pharma EEIG, Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH,
United Kingdom CONTACT IN AUSTRIA: Bristol-Myers Squibb GesmbH, Vienna,
Tel. +43 1 60143 -0 NR, prescription only. DATE OF LAST REVISION: July 2016
Further information, especially in regards to special warnings and precautions
for use, Interactions with other medicinal products or other forms of interaction,
pregnancy and lactation as well as undesirable effects are to be extracted from the
published Summary of Product Characteristics (SmPC).
1506AT16PR11523-04 10/16
© 2016 Bristol-Myers Squibb Company